POSACONAZOLE
- Product NDC
- 55150-388
- 11-digit product format
- 551500388
- Labeler code
- 55150
- Product ID
- 55150-388_6d1e5905-71b9-480b-82ae-5c92a2374e1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POSACONAZOLE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA214842
- Marketing category
- ANDA
- Marketing start
- 2023-12-26
- Substance
- POSACONAZOLE
- Active strength
- 18 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- POSACONAZOLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POSACONAZOLE | 18 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
| Rxcui | 1492043 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-388-01 | POSACONAZOLE | 16.7 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 16.7 | | 3 |
| 55150-388-01 | POSACONAZOLE | 1 in 1 CARTON | INJECTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-388 | POSACONAZOLE INJECTION [EUGIA US LLC] | 2 | Current NDC, 2 package rows | 20241128_2e88e379-b712-4dec-97a2-c90ef3638372.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-388-01 | 55150038801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSE | 2023-12-26 | No | No | Current |